FDA.reportPublic FDA data

DEPUY (IRELAND)

Matched from indexed company URL: Depuy (Ireland)

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96166713002854251DEPUY (IRELAND)1N2026-01-01LOUGHBEG RINGASKIDDY CO. CORK Munster IE --

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
10603295079941AML EXCEL - AML EXCEL T-HANDLE+1(800)255-2500xx@xx.xx
10603295080008AML EXCEL - AML EXCEL CALCAR MILL SMALL+1(800)255-2500xx@xx.xx
10603295080015AML EXCEL - AML EXCEL CALCAR MILL MEDIUM+1(800)255-2500xx@xx.xx
10603295080022AML EXCEL - AML EXCEL CALCAR MILL LARGE+1(800)255-2500xx@xx.xx
10603295080145NA - IM INITIATOR STEPPED+1(800)255-2500xx@xx.xx
10603295080770NA - ANTEVERSION OSTEOTOME MEDIUM+1(800)255-2500xx@xx.xx
10603295080787NA - ANTEVERSION OSTEOTOME LARGE+1(800)255-2500xx@xx.xx
10603295080794NA - ANTEVERSION OSTEOTOME SMALL+1(800)255-2500xx@xx.xx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
38331557871379P960001DEPUY 1 BONE CEMENTLOD1997-02-11
38331494980439P830055LCS(R) TOTAL KNEE SYSTEMNJL1985-04-12
38331056179924P070026CERAMAX CERAMIC HIP SYSTEMMRA2010-12-23
38331548828976K983014SUMMIT ACETABULAR SYSTEMLPH1998-10-27
38331886117902K980801J-FX BIPOLAR HEADKWY1998-05-29
38331247773483K980513ARTICUL/EZE FEMORAL HEADSJDI1998-04-14
38331250351392K971189P.F.C. SIGMA KNEE SYSTEM (SIZE 1.5)JWH1997-07-17
38331263237939K961939S-ROM FEMORAL HIP STEM(SIZES 12 X 06 X 115 AND 12 X 07 X 115)LPH1996-08-13
38331238752491K961685P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5)JWH1996-07-10
38331316430613K955511ARTHOPOR I & II ACETABULAR CUP/ARTHOPOR II OBLONG ACETABULAR CUPLPH1996-02-26
38331077147520K954935S-ROM FEMORAL HIP STEM - SIZE 14 X 8LPH1996-01-22
38331550520664K953202P.F.C. SIZE 0 CEMENTED FEMORAL COMPONENTJDI1996-01-31
38331309631112K953200ULTIMA SIZE 0 CEMENTED FEMORAL STEMJDI1996-01-31
38331941211282K950010DARWIN KNEE SYSTEM (CRUCIATE SUBSTITUTING) POROUS COATED AND NON-POROUS COATEDJWH1995-05-15
38331577246738K944538GAS PLASMA STERILIZATIONHRY1995-09-26
38331491511371K943727BIOSTOP G BONE CEMENT RESTRICTORLZN1995-05-11
38331130397448K943462DARWIN KNEE SYSTEMJWH1994-12-21
38331561113698K934412COATED ZT PROXIMAL SLEEVELPH1994-06-03
38331990643916K924379ULTIMA(TM) TOTAL HIP SYSTEM CEMENTED FEMORAL STEMKWL1993-02-12
38331209065357K913231S-ROM(TM) TOTAL LHIP SYSTEM W/CERAMIC HEADJDI1991-12-20
38331194996645K912713S-ROM ZT HA PROXIMAL FEMORAL SLEEVEMEH1991-12-30
38331116135170K910664MOD. TROCHANTER SCREW & WASHER W/ ANODIZED TITAN.LWJ1992-04-01
38331367800818K900832MODIFIED DEPUY ACETABULAR CUP SYSTEM* HIP ACETA.JDI1990-05-04
38332066035988K900638P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENTKWL1990-04-30
38332069268311K893872P.F.C. HIP SYSTEM POROUS COATED FEMORAL COMPONENTKWY1989-09-11
38331270187621K891083CERAMIC TOTAL HIP BALL HEAD, SMALL TAPERLZO1989-06-09
38331788653275K884796P.F.C.(TM) MODULAR KNEE SYSTEMJWH1989-03-29
38331203479195K851422S-ROM 135 FEMORAL STEM & COLLAR(PART OF S-ROM HIPJDI1985-09-18
38331532586721K843909TITANIUM HIP 1019JDI1984-11-15
38331226169041K800894DUPUY CEMENT RESTRICTOR TRIALS & INSTR.JDI1980-05-02
38331836558053K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR ConditionalMEH2024-01-19
38331811461552K213839DePuy Corail AMT Hip ProsthesisLZO2022-01-06
38331896324264K212683GLOBAL ICON Stemless Shoulder SystemPKC2022-01-19
38331284944172K202472ACTIS Duofix Hip ProsthesisLPH2020-10-21
38331193530454K193398Summit DuoFix HA CoatingMEH2020-02-04
38331333509039K192448Delta Xtend Revers Shoulder SystemPHX2019-10-04
38332067528202K190344DePuy Corail AMT Hip ProsthesisLZO2019-11-01
38331861367845K183077Delta Xtend Reverse Shoulder SystemPHX2019-05-17
38331209567268K173960DePuy Corail AMT Hip ProsthesisLZO2018-09-21
38332050340121K170806ATTUNE Cemented Tibial Base, Fixed BearingJWH2017-06-15
38331409076165K170748GLOBAL UNITE Platform Shoulder SystemPHX2018-01-11
38331886494978K160907DePuy Actis DuoFix Hip ProsthesisMEH2016-07-19
38331504487111K160700ATTUNE Revision Knee SystemJWH2016-06-10
38331309884721K150862DePuy Actis Duofox Hip ProsthesisMEH2015-09-25
38331628440586K140881DEPUY ATTUNE KNEE SYSTEM - CEMENTLESS CR AND PS FEMORAL COMPONENETSMBH2015-02-13
38332004058593K133834DEPUY GLOBAL UNITE SHOULDER SYSTEMKWS2014-04-03
38331652201581K122442DEPUY CTA REVERSE SHOULDER SYSTEMPHX2012-09-06
38331402058729K120599DEPUY M-SPEC 36MM FEMORAL HEADSLPH2013-04-30
38331234894133K120174DEPUT DELTA XTEND REVERSE SHOULDERPHX2012-06-11
38331057059364K111433DEPUY STTUNE (TM) PS KNEE SYSTEMOIY2011-08-30
38331539949753K103756DEPUY ATTUNE TOTAL KNEE SYSTEMOIY2011-03-15
38331244722575K102080DEPUY RECLAIM REVISION HIP SYSTEMLZO2010-11-23
38331491703285K101996DEPUY GLOBAL UNITE SHOULDER SYSTEMPHX2010-12-15
38331610533340K101433DEPUY ATTUNE KNEE SYSTEMOIY2010-12-10
38331057133322K100391DEPUY UNIVERSAL GRIPTION TF CONESJWH2010-09-29
38331000330744K091751DEPUY DELTA XTEND REVERSE SHOULDER XLK CUPKWS2009-07-14
38331845139393K082585DEPUY ASPHERE M-SPEC HEADKWA2008-12-04
38331818668797K082500DEPUY SIGMA CR-F FEMORAL COMPONENTJWH2008-11-18
38331364167462K081620MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEMKWS2008-06-30
38331335932668K081163SMARTSET GMV GENTAMICIN BONE CEMENTMBB2008-05-14
38331555432722K081155SMARTSET MV BONE CEMENTLOD2008-05-14
38331919300293K073676DEPUY DELTA XTEND REVERSE SHOULDER HIGH MOBILITY CUPPHX2008-01-29
38331318193758K073529DEPUY SIGMA PS FEMORAL COMPONENTSJWH2008-01-24
38331001871233K071830DEPUY DELTA TS CERAMIC FEMORAL HEADSLZO2007-09-28
38331869836771K071417DEPUY LPS DIAPHYSEAL AND METAPHYSEAL SLEEVESMBH2007-08-02
38332049400326K071379DELTA XTEND REVERSE SHOULDER MODULAR STEMPHX2007-09-11
38331878845367K062748MODIFICATION: TO DEPUY DELTA CERAMIC FEMORAL HEADLZO2006-11-30
38331141358746K062250DELTA XTEND REVERSE SHOULDER SYSTEMPHX2007-02-02
38331819438600K062116DELTA CTA REVERSE SHOULDER SYSTEM HUMERAL HEADSPHX2006-08-18
38331383084847K061221DUPUY S-ROM STD HIP STEM PROSTHESISKWA2006-08-28
38331921549294K061144DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENTMBB2006-06-08
38332003668800K060031DEPUY MODULAR M HEADSLPH2006-01-31
38331169292206K053445SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENTLOD2006-01-06
38332045365682K053003DEPUY CMW 1, 2 AND 3 BONE CEMENTSLOD2005-11-22
38331913446617K053002DEPUY CMW 1 GENTAMICIN BONE CEMENTMBB2005-11-22
38332044807392K050315DELTA HUMERAL CUPSPHX2005-05-16
38331852583203K041656MODIFICATION TO DEPUY 1 GENTAMICIN BONE CEMENT AND SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENTLOD2004-07-01
38331376560871K040644MODIFICATION TO DEPUY CERAMIC FEMORAL HEADLZO2004-04-08
38331158639598K040268DEPUY PRESERVATION UNICONDYLAR TIBIAHRY2004-05-05
38331807273243K040166DEPUY SIGMA XLK TIBIAL INSERTSJWH2004-02-23
38331341079843K033563SMARTSET GHV GENTAMICIN BONE CEMENTLOD2004-02-05
38331885347714K033382SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENTLOD2004-02-05
38331573109739K033273DEPUY PINNACLE ACETABULAR CUP SYSTEM, ESL MARATHON POLYETHYLENE LINERS, AND DEPUY ULTIMA UNIPOLAR FEMORAL HEADSLPH2004-05-06
38331798321958K033272DEPUY SIGMA TIBIAL INSERTSJWH2004-02-05
38331345018264K032151DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYSJWH2003-09-26
38331139265456K031803DEPUY CERAMIC FEMORAL HEADSLZO2003-07-01
38331981832239K023103DEPUY 1 GENTAMICIN BONE CEMENTLOD2003-09-29
38331544046619K023012SMARTSET HV BONE CEMENTLOD2003-02-13
38331006769516K021478DELTA SHOULDERPHX2003-11-18
38331471540847K011533DEPUY FEMORAL HEADSLZO2002-01-28
38332010155040K010171DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LINERLPH2001-04-06
38331749881333K001534PINNACLE ACETABULAR SYSTEMLPH2000-06-12
38331386210700K000306PINNACLE ACETABULAR SYSTEMLPH2000-03-23
38331002379245
38331005126228
38331030448231
38331081022463
38331085776252
38331092354480
38331111573509
38331174317442
38331190570014
38331213929095
38331251053747
38331270941603
38331280810349
38331306976916
38331312089002
38331355302436
38331358651161
38331385863193
38331400898936
38331405093364
38331411184221
38331424947010
38331448068685
38331456739312
38331466837280
38331490090988
38331500585269

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JWH132017-06-15
LPH122020-10-21
PHX122019-10-04
LZO102022-01-06
LOD82008-05-14
JDI81998-04-14
MEH52024-01-19
KWS32014-04-03
OIY32011-08-30
MBB32008-05-14
MBH22015-02-13
KWA22008-12-04
HRY22004-05-05
KWY21998-05-29
KWL21993-02-12
PKC12022-01-19
MRA12010-12-23
LZN11995-05-11
LWJ11992-04-01
NJL11985-04-12

PMN#

GUDID#

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